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Saizen
Overview
What is Saizen?
SAIZEN is a human growth hormone produced by recombinant DNA technology. SAIZEN has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. SAIZEN is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene.
SAIZEN is a sterile, non pyrogenic, white, lyophilized powder intended for subcutaneous injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5.
What does Saizen look like?
What are the available doses of Saizen?
SAIZEN lyophilized powder (to be reconstituted with Bacteriostatic Water for Injection):
SAIZEN click.easy reconstitution device:
saizenprep reconstitution device:
What should I talk to my health care provider before I take Saizen?
How should I use Saizen?
SAIZEN (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.
For subcutaneous injection.
SAIZEN therapy should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency or adult patients with either childhoodonset or adult-onset growth hormone deficiency.
What interacts with Saizen?
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What are the warnings of Saizen?
Sorry No Records found
What are the precautions of Saizen?
Sorry No Records found
What are the side effects of Saizen?
Sorry No records found
What should I look out for while using Saizen?
Acute Critical Illness ()
Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death ()
Active Malignancy ()
Hypersensitivity to somatropin or excipients ()
Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ()
Children with closed epiphyses ()
What might happen if I take too much Saizen?
How should I store and handle Saizen?
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Somatropin (as well as endogenous growth hormone) binds to dimeric growth hormone receptors located within the cell membranes of target tissue cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-1 produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of somatropin (e.g., lipolysis)
Non-Clinical Toxicology
Acute Critical Illness ()Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death ()
Active Malignancy ()
Hypersensitivity to somatropin or excipients ()
Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ()
Children with closed epiphyses ()
Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin . Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk.
The following important adverse reactions are also described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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